Pharmaceutical Manufacturing QA Associate (2nd Shift)

POSITION SUMMARY:The Manufacturing QA Associate contributes to Quality Assurance on the floor activities related to drug substance manufacturing. The colleague uses fundamental knowledge of GMP, and established procedures methodologies to provide quality oversight of manufacturing documentation, housekeeping, and overall GMP compliance.  The Associate ensures the site performs in a state of compliance by contributing to Quality oversight activities while fostering an empowered culture of quality across all functions.CORE JOB DUTIES:Performs duties with the guidance of Sr. AssociatesExecute real time review of batch documentation and other manufacturing documentation analyzing for errors, corrections, and complianceSupport Transfer Master Cell Banks to ManufacturingPerform housekeeping and GMP walkthroughs of facilityInitiate deviations in real time and assists in investigationsWork in cross functional teams to meet and exceed timelinesExecute or review room and line clearancesMakes quality decision in real time according to regulations ICH Q7 and 21CFR211 and internal proceduresADDITIONAL RESPONSIBILITIESSupport/initiate analytical test results initial investigation on the floorReviews and may approve manufacturing analytical testing on the floorUses analytical skills to help ensure shop floor compliance to internal standards and proceduresDraft and review Standard Operating ProceduresWork independently and with minimal supervisionProvides excellent communicationPerform other duties as assigned and take ownership to support the implementation of activities needed including but not limited to facility start-up and continuous operations.